Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01440647
Recruitment Status : Completed
First Posted : September 26, 2011
Results First Posted : March 12, 2013
Last Update Posted : March 12, 2013
Information provided by (Responsible Party):
Olga Sorina, Women and Infants Hospital of Rhode Island

Brief Summary:
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Procedure: Extubation to NIPPV Procedure: Extubation to CPAP Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study
Study Start Date : November 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: NIPPV
Extubation to NIPPV (nasal intermittent positive pressure ventilation)
Procedure: Extubation to NIPPV
After extubation infants were placed on NIPPV as soon as all the extubation criteria were met
Other Name: NIPPV
Active Comparator: CPAP
After extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life
Procedure: Extubation to CPAP
After extubation infants were placed on CPAP
Other Name: CPAP

Primary Outcome Measures :
  1. Number of Days Being Intubated [ Time Frame: 30 days from birth ]

Secondary Outcome Measures :
  1. Percentage of Participants With Reintubation [ Time Frame: 0-7 days post-extubation ]
    Reintubation rate is a measure of the efficacy of NIPPV.

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria.
  • Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life.
  • Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz.
  • Infants who have never been previously extubated.

Exclusion Criteria:

  • Infants enrolled in competing trials.
  • Participation refused by parent/attending physician/ parent unavailable for consent.
  • Infants with any major congenital abnormality.
  • Postoperative patients from any surgery.
  • Infants in extremis/decided upon not to receive intensive care.
  • Ventilator settings lower than the intervention group.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01440647

United States, Rhode Island
Women and Infants Hospital of RI
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Principal Investigator: Olga A DeSimone, MD The Floating Hospital for Children at Tufts Medical Center
Study Director: Abbot R Laptook, MD Women and Infants Hospital of RI

Responsible Party: Olga Sorina, Principal Investigator, Women and Infants Hospital of Rhode Island Identifier: NCT01440647     History of Changes
Other Study ID Numbers: 07-0090
First Posted: September 26, 2011    Key Record Dates
Results First Posted: March 12, 2013
Last Update Posted: March 12, 2013
Last Verified: February 2013

Keywords provided by Olga Sorina, Women and Infants Hospital of Rhode Island:
Respiration, Artificial
Infant, Premature
Bronchopulmonary Dysplasia
Continuous Positive Airway Pressure
Non-Invasive Positive-Pressure Ventilation
Intermittent Positive-Pressure Ventilation
High-Frequency Ventilation

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases